Clearance of Vasoactive Metabolites With Blood Purification

Study acronym: VITAL
StatusUnknown
PhaseNot specified
Started

Record status This record was last updated September 19, 2024 (before its estimated March 11, 2026 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date changed from estimate of Apr 1, 2024 to Jul 11, 2024
    • Study sites: 2 to 3
    • Primary completion date: Dec 1, 2025 to Mar 11, 2026
    • Study completion date: Mar 1, 2026 to Jun 11, 2026
  3. Notable Start date: Dec 1, 2023 to Apr 1, 2024
    • Primary completion date: Aug 1, 2025 to Dec 1, 2025
    • Study completion date: Nov 1, 2025 to Mar 1, 2026
    v3
  4. Notable Start date: Nov 1, 2023 to Dec 1, 2023v2 Show 4 more changesShow less
    • Primary completion date: Jul 1, 2025 to Aug 1, 2025
    • Study completion date: Oct 1, 2025 to Nov 1, 2025
    • Secondary endpoints revised (6)
    • Study description shortened, about 18 words
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Extracorporeal blood purification is a supportive therapy in the management of patients with sepsis or vasoplegic shock. The pathophysiology of sepsis is based on an inappropriate host response to infection. Certain medical devices with higher adsorption capacity make it possible to limit this inappropriate response and could thus improve the hemodynamics of patients in septic or vasoplegic shock. The preliminary experience of the investigators from clinical data of vasopressor withdrawal in pediatric patients treated with oXiris shows a 50% reduction in the vasopressor score, Vaso Inotropic Score (VIS), for 40% of patients within 24 hours following the start of treatment. Similar results were found in adult patients treated for severe COVID-19 or vasoplegic shock by the other centers participating in the study. Cytokine purification is an important physiological effect of purification membranes. However, this may not fully explain the rapid hemodynamic improvement of patients treated with an oXiris membrane. The role of angiotensin metabolites (Ang 1-5, 1-7, 1-9) in the systemic vascular tone of patients has been recently discussed. The administration of angiotensin 2 in vasoplegic shock in adults helps correct hypotension. In the group of patients with increased renin, this treatment was associated with a reduction in mortality. Indeed, increased renin associated with dysfunction of Angiotensin Converting Enzyme (ACE) leads to an accumulation of Angiotensin 1 which degrades to Ang 1-7. The hypothesis f the investigators is that the concentration of Ang 1 and Ang 1-7 is elevated in cases of vasoplegic shock and that the clearance of these vasodilator peptides by blood purification is associated with clinical improvement.
Trial Details
NCT Number NCT06109142
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions
(from sponsor)
Critically Ill Patients
Related terms Shock, Septic
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov